Quality Control Analyst

Quality Control Analyst III in Rensselaer, NY - NightsBuild your future at Curia, where our work has the power to save livesCuria is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.We proudly offerGenerous benefit options (eligible first day of employment)Paid training, vacation and holidays (vacation accrual begins on first day of employment)Career advancement opportunitiesEducation reimbursement401K program with matching contributionsLearning platformAnd more!Position overviewThe Quality Control Analyst III is responsible for supporting the manufacturing department and external customers. Routine functions include testing of raw materials, in-process, end product, and stability samples.To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Essential job dutiesPerform complex testing and data evaluation such as TGAPerform complex Liquid/Gas Chromatography, UPLC, and other testing, and, as needed, troubleshoot issuesParticipate in or assist with test method validationsEvaluate data for trendsSupport supervisors in OOS Investigations and complete CAPA requirementsInteract with outside departments including attending meetings, providing updates, etc.Coordinate testing performed at outside testing labs, raw materials, etc.Maintain a detailed and accurate recording of activities and results on paperworkExecute, author, and review SOPs, reports, protocols, investigations, change controls, and data summaries. Understand and use basic risk assessment and root cause toolsTrain upon and understand methods, equipment and standard operating proceduresProvide training to others as needed. Attend internal and external training on related subjects, including both intra- and inter-departmental cross-training on new techniques and proceduresSupport equipment upkeep and laboratory method trouble shootingProvide technical assistance during the shift for test method trouble shootingPrepare and order supplies, as necessaryEnter data into relevant data management systems. Perform tracking and trending of data as requested. Compile data and provide data summaries to managementUtilize a thorough understanding of regulatory and compliance guidelines for the pharmaceutical industryInteract with other departments within the company for testing needs and schedulingMay lead departmental projects with the opportunity to participate in or lead cross-functional teams, including continuous improvement projects and new customer teamsMay lead stability program including management of test points, reporting of data, and investigations of out of specification or aberrant stability resultsEducation, experience, certification and licensures Required· Bachelor's degree in Chemistry or related field· Minimum 5-7 year's pharmaceutical experience or equivalent combination of education and experiencePreferred· Experience working in cGMP or GLP pharmaceutical industry environmentKnowledge, skills and abilitiesExcellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general publicAbility to meet deadlines and work under pressure with limited supervisionStrong time management and organizational skills with the ability to multi-task and manage multiple projects independentlyAbility to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulationsAbility to write reports, business correspondence, and procedure manualsAbility to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutationsAbility to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysisAbility to define problems, collect data, establish facts, and draw valid conclusionsAbility to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variablesProficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systemsKnowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plusPhysical requirementsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; or sit; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.Work environmentThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this Job, the employee is frequently exposed to fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.Pay Range: $74,000 - $92,000Education, experience, location and tenure may be considered along with internal equity when job offers are extended.Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer. curiate.co